Mr. John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
Verification vs. Validation – Product¸ Process or Equipment, Software and QMS
Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validatio ...
- Basic & Intermediate
- 90 Mins
Human Factors Engineering to Satisfy the New IEC 62366-1, -2
Part 1, IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 9-stage process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability ...
- Basic & Intermediate
- 90 Mins
Powerful Closed-loop CAPA - Meeting FDA Expectations
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) are major components of product complaint, non-conformance, and OOS failure investigations, and hazard analysis/risk management and mitigation activities, as well as ...
- Intermediate
- 90 Mins
The New Usability Engineering Standard in IEC 62366-1:2015- Application and IEC/TR 62366-2:2- Guidance on Application to Medical Devices
IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 -- Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on ...
- Intermediate
- 90 Mins
Risk-based CAPA Systems
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance and OOS failure investigations and hazard analysis/risk management and mitigation activities, as well as produc ...
- Basic & Intermediate
- 90 Mins
DHF, DMR, DHR and Technical File / Design Dossier - Including New ISO 13485:2016 and EU MDR Requirements
This webinar will discuss the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also ...
- Intermediate
- 60 Mins
10 Steps to Effectual Risk Analysis for US FDA and ISO 14971 Compliance
Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support ...
- Basic & Intermediate
- 90 Mins
Master Validation Planning to meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 requirements
This 90-minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And ...
- Intermediate
- 90 Mins
10 Steps to Effectual Risk Analysis for US FDA and ISO 14971 Compliance
Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to suppor ...
- Basic & Intermediate
- 90 Mins
Implementing the New Usability Engineering Standard -- IEC/TR 62366-2:2 Part 2: Guidance on Application
IEC has released a new explanation of its updated, medical device usability standard, IEC 62366-1:2015, with its “how” (to implement), IEC/TR 62366-2:2 Part 2: “Guidance on the application of usability engineering to medical devices.” This Part 2 ...
- Intermediate
- 90 Mins